Highlights of the Bill

The Drugs and Cosmetics (Amendment) Bill, 2005 seeks to amend the Drugs and Cosmetics Act, 1940. It enhances penalties for certain offences and provides for special courts to try offences related to spurious and adulterated drugs.

The Drugs and Cosmetics (Amendment) Bill, 2007 seeks to replace the Drugs Technical Advisory Boards for allopathic and Indian systems of medicine with the Central Drugs Authority (CDA). Drug consultative committees may be established to advise the CDA and central and state governments.

The CDA shall be the licensing authority for the manufacturing, distribution, sale, import and export of drugs and cosmetics. It shall also recommend to the central government standards for drugs and cosmetics, measures to regulate clinical trials, etc.

The 2007 Bill expands the definition of “drugs” to include medical devices. It also defines “clinical trial”, states that all clinical trials require the approval of the CDA, and prescribes penalties for any person violating this provision.

Key Issues and Analysis

The Standing Committee has submitted its recommendations on the 2005 Bill. It recommended enhanced penalties for spurious and adulterated drugs that lead to prolonged illness. It also suggested separate courts for trying offences under the Act.

The CDA shall be the licensing authority for the manufacture, sale or stocking of drugs and cosmetics. Currently, these functions are delegated to state governments.

The 2007 Bill does not mandate medical and scientific experts in the CDA. A member can be any person with special knowledge of and a minimum of 15 years professional experience in the pharmaceutical industry, public administration, finance or law.

The Mashelkar Committee made various recommendations with regard to strengthening the drug regulatory system and the problem of adulterated and spurious drugs. Whereas several of these recommendations are being implemented through these Bills, neither Bill addresses the recommendations related to strengthening drug regulation at the state level.